Device product
HUDSON RCI SHERIDAN SHERI-BRONCH Endobronchial Tube REF 5-16135 - Product Usage: The Sheridan Endobronchial Tubes are intended for use in Thoracic surgery, brochospirometry, adminitration of endobronchial anesthesia and other uses commonly requiring endobronchial intubation. The Sheridan Endobronchial tube is indicated for main stem bronchus intubation and allows for selective inflation or deflation of either lung.
Z-0703-2020
Product summary
- Firm
- Teleflex Medical
- Event
- Event 84298
- Status
- Terminated
- Classification
- Class II
- Quantity
- 53 units
- Official record key
device-enforcement:Z-0703-2020
Official wording
Reason: The tracheal and brochial swivel connectors are incorrectly labeled.
Code information: Catalog: 5-16135; Manufacturing Lot: 73G1600257
Distribution pattern: US Nationwide distribution in the states of CT, OK, LA, IL, GA, NY, CA, MT, MI, MA, FL.
Derived failure modes
-
Labeling or packaging
incorrectly labeled